NCT01521910

Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the investigators study was to determine the effect of dietary protein restriction on survival and progression to end stage renal disease (ESRD) in diabetic nephropathy.

Detailed description

The study was a prospective, randomized, unmasked, controlled trial carried out at the Steno Diabetes Center. With concealed randomization the patients were (in blocks of two according to the level of GFR) assigned to receive either a usual-protein diet or a low-protein diet. After randomization an iso-caloric low-protein diet of 0.6 g/kg/day was prescribed to patients in the low-protein diet group. The usual-pro tein diet consisted of the patients' pre-study diet. The planned duration of follow-up was four years, scheduled visits every three-months. All patients gave complete history of medication, underwent examination of weight, urinary albumin-, sodium- and urea excretion, serum albumin, serum urea, hemoglobin, hemoglobin A1c, blood pressure, serum total-cholesterol, high-density lipoprotein (HDL) cholesterol. GFR, serum triglycerides,calcium and phosphorous, anthropometric measurements, nutritional status and smoking habits were evaluated every six months. Dietary protein intake was estimated on the basis of three consecutive 24-hour urine samples completed before each visit, using urinary excretion of urea nitrogen. GFR was measured by plasma clearance of 51Cr-EDTA over a 4 hour period and standardized for 1.73m2 body surface area using the same surface for each patient during the study.

Conditions

• Type 1 Diabetes Mellitus With Diabetic Nephropathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	low protein diet	An iso-caloric low protein diet of 0.6 g/kg/day was prescribed during the whole study duration. The same dietician gave nutritional advices at least every three months during the whole study period. Patients were also seen by the same doctor during each visit for the whole study period. Supplementation of Calcium of 500mg/day. Urine albumin losses \>= 2 g/day wre replaced by increasing dietary protein on a gram-for-gram basis, only if the patient was compliant with the prescribed low-protein diet.
DIETARY_SUPPLEMENT	normal protein diet	The patients pre-study diet during the whole study period Patients were also seen by the same doctor during each visit for the whole study period.

Timeline

• Start date: 1995-04-01
• Primary completion: 2000-06-01
• Completion: 2000-06-01
• First posted: 2012-01-31
• Last updated: 2012-01-31

Locations

1 site across 1 country: Denmark